Regulatory Information Systems Manager

Summary: The role of Regulatory Information Systems Manager involves leading the implementation and maintenance of Regulatory Information Management Systems (RIMS), with an emphasis on labeling, data governance, and system integration. The position is remote and requires a commitment of 25 hours per week, with the potential to increase to 40 hours. The ideal candidate should possess significant experience in label management and system implementation, particularly with Veeva systems. Familiarity with additional platforms and strong project management skills are also beneficial.

Key Responsibilities:

• Lead the implementation and maintenance of Regulatory Information Management Systems (RIMS).
• Focus on labeling, data governance, and system integration.
• Manage label management and system implementation processes.
• Oversee global submissions and ensure compliance with CTD/eCTD and IDMP/XEVMPD standards.
• Utilize project management skills to drive project success.

Key Skills:

• Label management & system implementation experience.
• Veeva system expertise.
• Familiarity with Generis or Freyr platforms (nice to have).
• Experience with CTD/eCTD and global submissions.
• Strong project management skills.

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other